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Dolutegravir/Lamivudine in Treatment-Naïve Pregnant Women (PREDUAL)

2026年9月15日 更新者：Maria Ines Figueroa、Fundación Huésped

Evaluating the Efficacy and Safety of Dolutegravir/Lamivudine (DTG/3TC) in ART-Naïve Pregnant Women

Protocol Number: FH-94

Study Objetives:

Primary:

  • To evaluate the virological response to Dolutegravir/Lamivudine in naive pregnant women with HIV who are starting antiretroviral therapy and vertical transmission in exposed neonates.

Secondary:

  • To evaluate the incidence of maternal adverse events.
  • To evaluate perinatal outcomes at delivery.
  • To evaluate maximum virological suppression at delivery.
  • To evaluate the incidence of changes in body weight exceeding what is expected for gestation.
  • To evaluate the immune response based on changes in CD4, CD8, and CD4/CD8 ratio values during pregnancy.
  • Assess baseline resistance and the development of resistance to virological failure to integrase inhibitors and INTRs during treatment with DTG+3TC or DTG+TDF/XTC or DTG+TAF/FTC.
  • To evaluate the incidence of HIV infection in children that breastfeed.
  • To evaluate safety outcomes and virological response of DTG+3TC compared to DTG+TDF/XTC or DTG+TAF/FTC.

Exploratory:

  • To explore the non-inferiority of DTG+3TC therapy compared to DTG+TDF/XTC or DTG+TAF/FTC treatment.
  • To evaluate the frequency of antiretroviral therapy withdrawal or modification before delivery.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

Primary endpoints:

  • Proportion of pregnant women who achieve an HIV-1 plasma viral load <200 copies/mL at delivery after starting DTG+3TC (Intention-to-Treat Exposed analysis).
  • Proportion of children born without HIV infection at 6 weeks & 6 months of age, defined by the negative result of negative virological tests (PCR) performed at birth (delivery visit and up to 72 hours after delivery), at 6 weeks, and at 6 months

Secondary endpoints:

  • Frequency of grade 2 or higher maternal adverse events, by type and severity, from baseline to 6 months postpartum.
  • Frequency of spontaneous abortion, preterm delivery, congenital malformations at birth or identified and reported during the first 6 month of life, or intrauterine fetal death.
  • Proportion of pregnant women with plasma viral load below 50 copies/mL at delivery.
  • Average total weight gain and BMI during pregnancy, compared with recommendations based on pre-pregnancy BMI.
  • Changes in CD4 lymphocyte count and CD4/CD8 ratio between baseline and delivery visit values.
  • Frequency and type of mutations according to the International AIDS Society (IAS-USA drug resistance mutations, 2025) mutation guidelines panel at the baseline visit and in case of virological failure at any time during the study.
  • Proportion of HIV infection among breastfed children.
  • Frequency of grade 2 or higher maternal adverse events, by type and severity, between the two arms. Frequency of pregnant women with plasma viral load <200 copies/mL in the two arms at delivery visit.

Exploratory endpoints:

  • Difference in the proportion of pregnant women who achieve an HIV-1 plasma viral load of less than 50 copies/mL at delivery between the DTG+3TC and DTG+TDF/XTC or DTG+TAF/FTC groups, to explore the non-inferiority of the dual regimen.
  • Proportion of participants requiring a change in antiretroviral regimen (due to lack of efficacy, adverse events, medical decision, or other reasons) before delivery.

Patient Population: HIV-1-infected Pregnant Women aged >16 years (>15 years for Brazil's sites) who are naïve to antiretroviral therapy Study design: Phase IV. Randomized, non-comparative, open-label, multicenter study.

Regimens: Dolutegravir 50 mg /lamivudine 300 mg QD FDC. Dolutegravir 50 mg QD plus tenofovir 300 mg/emtricitabine 200mg or plus tenofovir 300 mg/ lamivudine 300 mg or tenofovir alafenamide 25 mg/emtricitabine 200 mg.

Duration: 14 months approximately months (depending on gestational age at entry).

Sample size: 210 subjects

研究の種類

介入

入学 (推定)

210

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • アルゼンチン
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires、Buenos Aires、アルゼンチン、C1155AHD
        • 募集
        • Hospital General de Agudos Dr. Cosme Argerich
        • コンタクト：
        • 主任研究者：
          • Diego Cecchini, MD
      • Ciudad Autónoma de Buenos Aires、Buenos Aires、アルゼンチン、C1188AAF
        • 募集
        • Sanatorio Güemes
        • コンタクト：
        • コンタクト：
          • Sebastián Nuñez, MD
          • 電話番号：8384 / 8365 +54 11 4959-8200
          • メール：snunez@fsg.edu.ar
        • 主任研究者：
          • Verónica Lacal, MD
      • Ciudad Autónoma de Buenos Aires、Buenos Aires、アルゼンチン、C1425AGP
      • El Palomar、Buenos Aires、アルゼンチン、B1684
        • まだ募集していません
        • Hospital Nacional Profesor Alejandro Posadas
        • コンタクト：
        • 主任研究者：
          • Mariana Golikow, MD
      • Isidro Casanova、Buenos Aires、アルゼンチン、B1765
        • まだ募集していません
        • Hospital de Agudos Paroissien
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Pablo Garnica, MD
  • ブラジル
      • São Paulo、ブラジル、04037-030
        • まだ募集していません
        • RDSS - Ricardo Sobhie Diaz & Cia Solucoes Cientificas Ltda - Ricardo Diaz Scientific Solution
        • コンタクト：
        • 主任研究者：
          • Ricardo Sobhie Diaz, MD
    • Estado de Bahia
      • Salvador、Estado de Bahia、ブラジル、40110-160
        • まだ募集していません
        • Fundação Bahiana de Infectologia
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Carlos Brites, MD
    • Pernambuco
      • Curitiba、Pernambuco、ブラジル、80430-000
        • まだ募集していません
        • Complexo do Hospital de Clínicas da UFPR/Ebserh
        • コンタクト：
        • 主任研究者：
          • Monica Maria Gomes da Silva, MD
    • Rio Grande do Norte
      • Natal、Rio Grande do Norte、ブラジル、59075-070
        • まだ募集していません
        • Universidade Federal do Rio Grande do Norte
        • コンタクト：
        • 主任研究者：
          • Monica Bay, MD
    • Rio de Janeiro
      • Nova Iguaçu、Rio de Janeiro、ブラジル、26030-380
        • まだ募集していません
        • Hospital Geral de Nova Iguaçu
        • コンタクト：
        • 主任研究者：
          • Aline Santos Ramalho Teixeira Benevenuto, MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

All persons who are eligible must meet all of the following:

  1. Confirmed HIV-1 infection: All tests must use blood, serum, or plasma samples. Documentation may be obtained from medical records. HIV-1 positive is defined as having HIV-1 RNA in plasma ≥ 1000 copies/mL, plus one antibody test or two positive HIV antibody tests (two different rapid tests or one rapid test and one positive ELISA/EIE test). If any of these diagnostic test results are not available, they will be performed at the SCR visit. In all cases, an HIV viral load test will be performed.
  2. Not exposed to prior antiretroviral therapy (ART): No prior antiretroviral therapy, including exposure to PrEP and/or PEP in the last 6 months.
  3. Ability to sign the informed consent form.
  4. Plasma HIV-1 RNA ≥1000 copies/mL. Viral load from the last 30 days may be valid. . Age ≥ 16 years or older in Argentina, ≥ 15 years or older in Brazil. The participant must be of the age required in their country of residence to give legal informed consent. Otherwise, informed consent must be signed by a parent or legal guardian, according to country guidelines, in addition to the participant.

6. Pregnant at any gestational age up to 32 weeks at the time of the screening visit: Viable pregnancy with a gestational age ≤32 weeks, defined according to menstrual history and/or ultrasound. Note: If the menstrual history is unknown or if there is a discrepancy between the menstrual history and the ultrasound, the gestational age will be determined based on the best technology available at each center.

7. The participant intends to continue with the pregnancy.

Exclusion Criteria:

All eligible individuals must NOT meet any of the following criteria:

  1. Documented resistance to 3TC (presence of the M184V/I mutation) or DTG (defined as the presence of G118R, Q148 H/K/R, or R263K).
  2. Active hepatitis C infection. 3. Active hepatitis B (HBsAg positive or detectable HBV viral load in cases with isolated positive HBV anti-core).
  3. Hemoglobin <8 g/dL.
  4. Fetal abnormalities detected on ultrasound
  5. Concomitant medications required with possible drug interactions specified in section 5.10.
  6. ALT >=5 times the ULN, or ALT >=3xULN and bilirubin >=1.5xULN (with >35% direct bilirubin). Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification
  7. Presence of severe preeclampsia or other pregnancy-related events, in current or previous pregnancies, such as renal or hepatic abnormalities (grade 2 or higher proteinuria, elevated serum creatinine, CrCl <50 mL/min, total bilirubin, ALT, or AST).
  8. Active opportunistic infection at screening: active severe opportunistic infections and/or severe bacterial infection, including active tuberculosis or severe disease or unstable clinical condition within 14 days prior to study entry.
  9. Any patient or disease-related condition that, in the investigator's opinion, would prevent the patient from adhering to study medication or complying with study visits or procedures.
  10. Problematic drug and/or alcohol use, which in the opinion of the site investigator could interfere with therapeutic compliance with study requirements.
  11. Known allergy or sensitivity to any of the study medications or their formulations.
  12. Vomiting or any other reason generating inability to swallow medications due to a pre-existing active disorder that prevents proper swallowing and absorption of study medications.
  13. Creatinine Clearance of <30 mL/min . If a creatinine value was obtained within 30 days prior to the screening visit, it may be used to calculate the CrCl.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Experimental
Dolutegravir plus Lamivudine DOVATO: Dolutegravir 50mg/lamivudine 300 mg, FDC, 1 coformulated tablet QD
薬：Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO]
1 pill QD
他の名前：
  • BI-THERAPY
アクティブコンパレータ：Active Comparator

TDF/XTC or TAF/FTC plus Dolutegravir (XTC stands for lamivudine OR emtricitabine)

  • TDF/FTC 300/200 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD OR
  • TDF/3TC 300/300 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD
  • TAF/FTC 25/200 MG, 1 tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD
薬：TDF/XTC or TAF/FTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)
1 pill of each QD
他の名前：
  • トリプルセラピー

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
To evaluate the virological response to Dolutegravir/Lamivudine in pregnant women with HIV who are starting antiretroviral therapy and vertical transmission in exposed neonates
時間枠：From enrollment to the end of treatment at 6 months after delivery

Endpoints:

  • Proportion of pregnant women who achieve an HIV-1 plasma viral load <200 copies/mL at delivery after starting DTG+3TC (Intention-to-Treat Exposed analysis).
  • Proportion of children born without HIV infection at 6 weeks & 6 months of age, defined by the negative result of negative virological tests (PCR) performed at birth (delivery visit and up to 72 hours after delivery), at 6 weeks, and at 6 months.
From enrollment to the end of treatment at 6 months after delivery

二次結果の測定

結果測定
メジャーの説明
時間枠
- To evaluate the incidence of adverse maternal events.
時間枠：From enrollment to the end of treatment at 6 months after delivery
Frequency of grade 2 or higher maternal adverse events, by type and severity, from baseline to 6 months postpartum
From enrollment to the end of treatment at 6 months after delivery
- To evaluate perinatal outcomes at delivery
時間枠：From enrollment to the end of treatment at 6 months after delivery
Frequency of spontaneous abortion, preterm delivery, congenital malformations at birth or identified and reported during the first 6 month of life, or intrauterine fetal death.
From enrollment to the end of treatment at 6 months after delivery
- To evaluate maximum virological suppression at delivery
時間枠：From enrollment to the end of treatment at 6 months after delivery
Proportion of pregnant women with plasma viral load below 50 copies/mL at delivery.
From enrollment to the end of treatment at 6 months after delivery
- To evaluate the incidence of changes in body weight exceeding what is expected for gestation
時間枠：From enrollment to the end of treatment at 6 months after delivery
Average total weight gain and BMI during pregnancy, compared with recommendations based on pre-pregnancy BMI.
From enrollment to the end of treatment at 6 months after delivery
- To evaluate the immune response based on changes in CD4, CD8, and CD4/CD8 ratio values during pregnancy.
時間枠：From enrollment to the end of treatment at 6 months after delivery
Changes in CD4 lymphocyte count and CD4/CD8 ratio between baseline and delivery visit values.
From enrollment to the end of treatment at 6 months after delivery
- Assess baseline resistance and the development of resistance to virological failure to integrase inhibitors and INTRs during treatment with DTG+3TC, DTG+TDF/XTC or DTG+TAF/FTC.
時間枠：From enrollment to the end of treatment at 6 months after delivery
Frequency and type of mutations according to the International AIDS Society (IAS-USA drug resistance mutations, 2025) mutation guidelines panel at the baseline visit and in case of virological failure at any time during the study.
From enrollment to the end of treatment at 6 months after delivery
- To evaluate the incidence of HIV infection in children that breastfeed.
時間枠：From enrollment to the end of treatment at 6 months after delivery
Proportion of HIV infection among breastfed children
From enrollment to the end of treatment at 6 months after delivery
To evaluate safety outcomes and virological response of DTG+3TC compared to DTG+TDF/XTC or DTG+TAF/FTC. Part 1 of 2.
時間枠：From enrollment to the end of treatment at 6 months after delivery
Frequency of grade 2 or higher maternal adverse events, by type and severity, between the two arms.
From enrollment to the end of treatment at 6 months after delivery
To evaluate safety outcomes and virological response of DTG+3TC compared to DTG+TDF/XTC or DTG+TAF/FTC. Part 2 of 2
時間枠：From enrollment to the end of treatment at 6 months after delivery
Frequency of pregnant women with plasma viral load <200 copies/mL in the two arms at delivery visit
From enrollment to the end of treatment at 6 months after delivery

その他の成果指標

結果測定
メジャーの説明
時間枠
- To explore the non-inferiority of DTG+3TC therapy compared to DTG+TDF/XTC or DTG+TAF/FTC treatment.
時間枠：From enrollment to the end of treatment at 6 months after delivery
Difference in the proportion of pregnant women who achieve an HIV-1 plasma viral load of less than 50 copies/mL at delivery between the DTG+3TC and DTG+TDF/XTC or DTG+TAF/FTC groups, to explore the non-inferiority of the dual regimen.
From enrollment to the end of treatment at 6 months after delivery
- To evaluate the frequency of antiretroviral therapy withdrawal or modification before delivery.
時間枠：From enrollment to the end of treatment at 6 months after delivery
Proportion of participants requiring a change in antiretroviral regimen (due to lack of efficacy, adverse events, medical decision, or other reasons) before delivery
From enrollment to the end of treatment at 6 months after delivery

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Fundación Huésped

協力者

ViiV Healthcare

捜査官

  • 主任研究者：Pedro Enrinque Cahn, MD、Fundación Huésped

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年9月10日

一次修了 (推定)

2028年10月15日

研究の完了 (推定)

2028年10月15日

試験登録日

最初に提出

2026年5月14日

QC基準を満たした最初の提出物

2026年5月27日

最初の投稿 (実際)

2026年6月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月18日

QC基準を満たした最後の更新が送信されました

2026年9月15日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • FH-94

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD 共有時間枠

3 month after last patient last visit

IPD 共有アクセス基準

By request

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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